Wrong Site Surgery:
The myths, the realities,
the solutions
J. Robert Wyatt, MD, MBA
Otolaryngology – Head & Neck
Surgery
Baylor Health System
Dallas, Texas
Glenn Rothman, MD
Chairman, Department of Surgery
Head & Neck Oncology
Banner Desert Medical Center
Mesa, Arizona
Agenda

Introduction: speaker credentials

The problem: wrong site surgery

The mandate: JCAHO requirements

Case studies

New solution: Sitemarx stamp

Conclusion
www.sitemarx.com
2
Surgeon background
J. Robert Wyatt, MD, MBA:

Otolaryngology – Head and Neck Surgery

Expert consultant, Texas Medical Board

Board of Managers, Baylor Surgicare, North Garland

Executive Committee, North Texas ENT Associates

Medical legal consultant

Licensed pilot since 1982
www.sitemarx.com
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Surgeon background
Glenn Rothman MD:

Head and Neck Cancer Surgeon

Chairman, Department of Surgery

Medical-legal and Medical Board consultant

Sentinel Event leadership

JCAHO compliance consultant

Proposed “solution” unavailable
www.sitemarx.com
4
Agenda

Introduction: speaker credentials

The problem: wrong site surgery

The mandate: JCAHO requirements

Case studies:

New solution: Sitemarx stamp

Conclusion
www.sitemarx.com
5
Your surgeon makes errors

To err is human – every 15 seconds

8 errors = one accident

Active task vs. passive task

Faith in others reinforces errors

Multi-tasking increases errors

Aviation and nuclear safety principles not adopted by
healthcare industry
www.sitemarx.com
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Fundamentals of errors
Error Type
Description
Example
Prevention
Skill-based
errors
Familiar act, little Slips, lapses
attention
Rule-based
errors
Act requiring
application of
rules to familiar
event
Knowledgebased errors
Unfamiliar
Faulty strategy Stop, teach
situation, no rule, to solve problem decision making
problem solving
skills
task
Pay attention
Wrong rule,
Educate, critical
misapplication of thinking,
correct rule, non- accountability
compliant with
rule
www.sitemarx.com
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Learning from the experts


Aviation and Nuclear power expertise
Investigation versus problem-solving “Root-cause
Analysis”

Systems thinking versus get rid of the bad apples

Reliance on diagnostic tools versus reliance of
profound knowledge

Safety as a “core value” versus safety as a “priority”

STAR: stop…think…act…review
www.sitemarx.com
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Wrong site surgery:
The frequency debate

1 in 5,000 – 10,000 cases

Not an accepted risk of surgery

Near misses not tracked

Near misses not analyzed

Numbers debate undermines public trust

Corrective efforts compromised by the numbers
debate
www.sitemarx.com
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Impact of wrong site cases

Physical injury and possibly assault

Loss of faith in the healthcare providers

Surgeon litigation and licensure penalties

Hospital litigation and accreditation penalties

Indefensible public image risk

Undermines surgery team cohesion
www.sitemarx.com
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Agenda

Introduction: speaker credentials

The problem: wrong site surgery

The mandate: JCAHO requirements

Case studies:

New solution: Sitemarx stamp

Conclusion
www.sitemarx.com
11
Joint Commission mandate

Who gets site marked?

Who does the site marking?

What is the acceptable mark?

Who confirms the mark?

The “time out”
www.sitemarx.com
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Has JCAHO solved wrong site?

JCAHO has brought focus to the problem

JCAHO has required redundancy

JCAHO has improved provider “buy-in”

JCAHO mandated root cause analysis

JCAHO agrees there is no evidence these measures
have decreased the incidence of wrong site surgery

No requirement to track near-misses

Cases are reported voluntarily
www.sitemarx.com
13
Factors contributing to failures

“Captain of the Ship” mentality

Surgery team hierarchy

Culture of blame and punishment

Compelling incentives for speed

Little attention to near misses

Failure to adopt “best practices”

Litigation and confidentiality
www.sitemarx.com
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Agenda

Introduction: speaker credentials

The problem: wrong site surgery

The mandate: JCAHO requirements

Case studies:

New solution: Sitemarx stamp

Conclusion
www.sitemarx.com
15
Case 1: Correct and incorrect
sites both marked

RN spouse marked husband to avoid error

Wrong testicle removed

Betadine site preparation blurred the words leaving
both marks “the same”

Analysis: More than one mark means nothing unique
about the correct site
www.sitemarx.com
16
Case 2: Wrong site marked

Laparoscopic LEFT inguinal hernia repair

“L” placed on the RIGHT groin


Analysis: “R” and “L” didn’t hold meaning for the
team…added to confusion
Failure to correlate with medical record
www.sitemarx.com
17
Case 3: Imprecise site mark

Index finger surgery instead of ring finger

Neither finger was normal

Mark correctly identified the hand but not the digit

Analysis: Lack of specificity of the site mark

No rules to guide the team as to acceptability
www.sitemarx.com
18
Case 4: Authorship of site
mark unclear

Surgery intern marked wrong kidney

Nurse assumed attending initials

Attending assumed fellow initials

Patient assumed academia meant accuracy

Analysis: Relied on system of initials to avoid errors.

No one knew owner of site mark initials
www.sitemarx.com
19
Case 5: Site mark washed off

Correct knee marked by surgeon but incorrect knee
prepped for surgery

Surgery team members not bothered by lack of mark
as they frequently see the ink washed away in the
preparation

Analysis: The use of markers not specifically
designed for site marking caused failure because the
marker itself was unreliable
www.sitemarx.com
20
Agenda

Introduction: speaker credentials

The problem: wrong site surgery

The mandate: JCAHO requirements

Case studies:

New solution: Sitemarx stamp

Conclusion
www.sitemarx.com
21
A new solution…

A tool specifically engineered to reduce the risk of
wrong site procedures and facilitate meeting Joint
Commission requirements

This tool leads to a standardized system for surgery
site marking that does not vary from patient to
patient, or from surgeon to surgeon

This tool does not require significant change in
complex, ingrained human behavior
www.sitemarx.com
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The solution: Key requirements

A consistent and unambiguous mark

Able to withstand a skin prep

Does not introduce increased risk or complexity to
the preoperative process

No added risk of perioperative infection

Size allows for both accuracy and visibility

Meets or exceeds JCAHO requirements
www.sitemarx.com
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The Sitemarx stamp
www.sitemarx.com
24
Stamp benefits: Consistency

From patient to patient and surgeon to surgeon, the
same mark is used. This provides a visual
expectation in the OR. Industrial engineering has
shown that humans are visual creatures, and if a
subconscious visual expectation is not met it is
rapidly noted consciously

Ophthalmology nurses’ study of marks observed,
most common (50%) was “other”
www.sitemarx.com
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Stamp benefits: Unambiguous

The stamp face can be made to imprint an
unmistakable message - such as “CORRECT
SURGERY SITE”, “CORRECT”, or “GO”

With this system, every patient, with any surgeon,
can be marked uniformly and consistently

“X”, “R”,”L”, dots and arrows
www.sitemarx.com
26
Stamp benefits: Withstanding
the prep

The stamp will use an non-toxic ink designed for
marking skin. Testing has demonstrated that this ink
will withstand the sterile prep far better than current
markers

Most of the markers currently used withstand the
sterile prep very poorly. Standard medical inks were
not designed for this purpose

Orthopedic wrong site errors are the most common
and these cases have the most vigorous skin prep
www.sitemarx.com
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Stamp benefits: Reduced
infection risk

Current markers are frequently not sterile and often
used on multiple patients

The ink contained in some of the markers currently
used bear the warning label “avoid contact with
unprotected skin”

The stamp is individually packaged and sterilized for
single-use

Nosocomial infections account for ~50% of hospital
deaths
www.sitemarx.com
28
Stamp benefits: Reduced
complexity

Surgeons marking differently, neighboring hospitals
marking differently, and varying nursing expectations
are all sources of errors

The current marking methods unnecessarily
complicate what should be a straightforward task

Stoplights and Stop signs are all the same for a
reason
www.sitemarx.com
29
JCAHO requirements

A single use, sterile, indelible ink, disposable surgical
site marking stamp meets the JCAHO requirement
for a consistent, lasting, and unambiguous mark on
the surgical site

Use of the stamp in multiple facilities in the same
geographic area meets achieves consistency across
institutions. JCAHO recognizes that since physicians,
nurses, anesthesiologists and other health care
workers work in multiple institutions, consistency
between institutions, not just within an institution,
improves patient safety and decreases patient errors
www.sitemarx.com
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Case 1: Correct and incorrect
sites both marked

RN spouse marked husband to avoid error

Wrong testicle removed

Betadine site preparation blurred the words leaving
both marks “the same”

Analysis: More than one mark means nothing unique
about the correct site

Stamp is clearly and unambiguously intended for
the correct site only
www.sitemarx.com
31
Case 2: Wrong site marked

Laparoscopic LEFT inguinal hernia repair

“L” placed on the RIGHT groin

Analysis: “R” and “L” didn’t hold meaning for the
team…added to confusion

Failure to correlate with medical record

The consistency of the stamp eliminates
interpretation of the mark….a source of error
www.sitemarx.com
32
Case 3: Imprecise site mark

Index finger surgery instead of ring finger

Neither finger was normal

Mark correctly identified the hand but not the digit

Analysis: Lack of specificity of the site mark

No rules to guide the team as to acceptability

Stamp size (~2cm) facilitates precise site
marking, including small sites such as fingers
and toes
www.sitemarx.com
33
Case 4: Authorship of site
mark unclear

Surgery intern marked wrong kidney

Nurse assumed attending initials

Attending assumed fellow initials

Patient assumed academia meant accuracy

Analysis: Relied on system of initials to avoid errors.

No one knew owner of site mark initials

The mark made by the stamp is consistent from
surgeon to surgeon
www.sitemarx.com
34
Case 5: Site mark washed off

Correct knee marked by surgeon but incorrect knee
prepped for surgery

Surgery team members not bothered by lack of mark
as they frequently see the ink washed away in the
preparation

Analysis: The use of markers not specifically
designed for site marking caused failure because the
marker itself was unreliable

The ink used in the stamp is designed to
withstand a skin prep
www.sitemarx.com
35
Agenda

Introduction: speaker credentials

The problem: wrong site surgery

The mandate: JCAHO requirements

Case studies: failures to meet JCAHO measures

New solution: Sitemarx stamp

Conclusion
www.sitemarx.com
36
Conclusion

Wrong site and wrong patient surgery remains a
problem

Eliminating wrong site and wrong patient surgery will
require widespread utilization of principles of error
management, accepting safety as a core value

Healthcare leaders need to embrace a commitment
to studying our mistakes, developing best practices
and sharing solutions nationwide
www.sitemarx.com
37
Conclusion

However, many of the errors occurring today are
related to specific problems with the site marking
process

A single use, sterile, indelible ink, disposable surgical
site marking stamp provides a consistent, lasting,
and unambiguous mark on the surgical site

In a simple and easy to use manner, this device
addresses many of the problems with the current site
marking process that lead to wrong site and wrong
patient errors
www.sitemarx.com
38